Colon CancerPhase 1AlloMemNCT01113736
Pilot Study Evaluating the Efficacy of AlloMEM After Loop Ileostomy
A Phase 1 study testing AlloMEM™ in people with Colon Cancer and Rectal Cancer, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
The objective of this study is to investigate whether the use of Human Peritoneal Membrane (HPM) in a temporary loop ileostomy is beneficial to patients. Benefit will be defined, for purposes of this study, as a decrease in adhesions resulting in decreased operative time during ileostomy closure, with promotion of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer, Rectal Cancer
- What is being tested?
- AlloMEM™
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jul 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between 18 - 85 years old at the time of ileostomy formation
- Scheduled to undergo planned diverting loop ileostomy
Who cannot join
- Patients undergoing emergency surgery
- Patients with abdominal or pelvic abscess present at time of initial surgery
- Patients with a history of pulmonary embolism or deep vein thrombosis (DVT) within 1 year of surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Pilot Study Evaluating the Efficacy of AlloMEM in Prevention of Intraperitoneal Adhesions & Peritoneal Regeneration After Loop Ileostomy
The objective of this study is to investigate whether the use of Human Peritoneal Membrane (HPM) in a temporary loop ileostomy is beneficial to patients. Benefit will be defined, for purposes of this study, as a decrease in adhesions resulting in decreased operative time during ileostomy closure, with promotion of peritoneal remodeling.
Read the detailed description
A loop ileostomy is a common procedure used to divert fecal matter from anastomotic sites after abdominal surgeries. Major complications from creation and subsequent closure of a temporary loop ileostomy include: stoma retraction, stoma prolapsed, stenosis, herniation, intra-abdominal abscess, anastomotic leak, wound dehiscence. Small-bowel obstruction (SBO) was the most common complication. SBO is caused by adhesions in the surgical site, with narrowing or angulation of the intestine causing obstruction. Prevention of these adhesions may reduce the frequency with which SBO is seen after this surgery. Furthermore, surgery to close the ileostomy is complicated by the presence of adhesions which make dissection of the ileostomy difficult, and increase the risk of injury of the small intestine during dissection, prolonging the operation time in an effort to minimize risk to the patient.
AlloMEM™ is human peritoneal membrane designated by the Food and Drug Administration (FDA) for use as a homologous tissue where native peritoneum is absent or traumatized. The AlloMem™ is not regulated as a device and no 510k submission has been made by the FDA. AlloMem™ is allogeneic freeze-dried, irradiated human peritoneal membrane used as a soft tissue wound covering solely regulated under 361 HCT/P because by FDA definition it is: minimally manipulated; intended for homologous use only; does not involve the combination of cell or other tissues, and does not rely on the metabolic function of cells for its primary function. Two animal studies have shown that AlloMEM™ can help prevent intra-abdominal adhesions and provides the biological framework for peritoneal remodeling. By decreasing adhesions and providing a peritoneal remodeling capacity, both the time needed for ileostomy closure and the risk of enterotomy or seromyotomy would be reduced. The combination could lead to decreased complication rates and therefore decreased morbidity for the surgical patients requiring an ileostomy.
- Conditions
- Colon Cancer, Rectal Cancer
- Being tested
- AlloMEM™
- Keywords
- Ileostomy, Stenosis, Surgical Wound Dehiscence, Peritoneal, Colorectal Surgery
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Constriction, Pathologic, Surgical Wound Dehiscence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlloMEM™Biological
Also called Human Peritoneal Membrane
To investigate whether the use of HPM in a temporary loop ileostomy is beneficial to patients.
| Study group | Role | What they receive |
|---|---|---|
| Human Peritoneal Membrane: AlloMEM™ | Experimental | For use as a homologous tissue where native peritoneum is absent or traumatized. By decreasing adhesions and providing a peritoneal remodeling capacity, both the time needed for ileostomy closure and the risk of enterotomy or seromyotomy would be reduced. The combination could lead to decreased complication rates and therefore decreased morbidity for the surgical patients requiring an ileostomy. Receives: Biological: AlloMEM™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
If there is a decrease on adhesion formation of AlloMEM™ used in formation of a temporary loop ileostomy.
Change in adhesion formation will be analyzed via the primary outcome of ileostomy mobilization time during ileostomy closure and the secondary outcome of an adhesion grading scale.
Measured: Average 1 hour during formation of ileostomy
Secondary outcomes (1)
Decrease in operative time and a promotion of peritoneal remodeling
The objective of this study is therefore, to investigate whether the use of HPM in a temporary loop ileostomy is beneficial to patients. Benefit will be defined, for purposes of this study, as a decrease in adhesions resulting in decreased operative time during ileostomy closure, with promotion of peritoneal remodeling
Measured: During 3 month ileostomy closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2010 (estimated)
- Study startJan 2010
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Proxy Biomedical Limited
- Responsible party
- Sponsor
- Investigators
- Conor P. Delaney, MD, PhD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113736
- Sponsor's protocol ID
- 09-09-23
- Other IDs
- 09-09-23
- Acronym
- AlloMem
- Status last verified
- May 2022
- First submitted
- 12 Apr 2010
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jin J, Voskerician G, Hunter SA, McGee MF, Cavazzola LT, Schomisch S, Harth K, Rosen MJ. Human peritoneal membrane controls adhesion formation and host tissue response following intra-abdominal placement in a porcine model. J Surg Res. 2009 Oct;156(2):297-304. doi: 10.1016/j.jss.2009.04.010. Epub 2009 May 13.
PubMed 19628227Keller DS, Champagne BJ, Stein SL, Ermlich BO, Delaney CP. Pilot study evaluating the efficacy of AlloMEM for prevention of intraperitoneal adhesions and peritoneal regeneration after loop ileostomy. Surg Endosc. 2013 Oct;27(10):3891-6. doi: 10.1007/s00464-013-3004-6. Epub 2013 May 14.
PubMed 23670746
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating the Efficacy of AlloMEM in Prevention of Intraperitoneal Adhesions & Peritoneal Regeneration After Loop Ileostomy
- ClinicalTrials.gov ID
- NCT01113736
- Acronym / sponsor ID
- AlloMem / 09-09-23
- Conditions
- Colon Cancer, Rectal Cancer
- Keywords
- Ileostomy, Stenosis, Surgical Wound Dehiscence, Peritoneal, Colorectal Surgery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Proxy Biomedical Limited
- Study start
- Jan 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 30 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to investigate whether the use of Human Peritoneal Membrane (HPM) in a temporary loop ileostomy is beneficial to patients. Benefit will be defined, for purposes of this study, as a decrease in adhesions resulting in decreased operative time during ileostomy closure, with promotion of peritoneal remodeling.
Detailed description
A loop ileostomy is a common procedure used to divert fecal matter from anastomotic sites after abdominal surgeries. Major complications from creation and subsequent closure of a temporary loop ileostomy include: stoma retraction, stoma prolapsed, stenosis, herniation, intra-abdominal abscess, anastomotic leak, wound dehiscence. Small-bowel obstruction (SBO) was the most common complication. SBO is caused by adhesions in the surgical site, with narrowing or angulation of the intestine causing obstruction. Prevention of these adhesions may reduce the frequency with which SBO is seen after this surgery. Furthermore, surgery to close the ileostomy is complicated by the presence of adhesions which make dissection of the ileostomy difficult, and increase the risk of injury of the small intestine during dissection, prolonging the operation time in an effort to minimize risk to the patient.
AlloMEM™ is human peritoneal membrane designated by the Food and Drug Administration (FDA) for use as a homologous tissue where native peritoneum is absent or traumatized. The AlloMem™ is not regulated as a device and no 510k submission has been made by the FDA. AlloMem™ is allogeneic freeze-dried, irradiated human peritoneal membrane used as a soft tissue wound covering solely regulated under 361 HCT/P because by FDA definition it is: minimally manipulated; intended for homologous use only; does not involve the combination of cell or other tissues, and does not rely on the metabolic function of cells for its primary function. Two animal studies have shown that AlloMEM™ can help prevent intra-abdominal adhesions and provides the biological framework for peritoneal remodeling. By decreasing adhesions and providing a peritoneal remodeling capacity, both the time needed for ileostomy closure and the risk of enterotomy or seromyotomy would be reduced. The combination could lead to decreased complication rates and therefore decreased morbidity for the surgical patients requiring an ileostomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Human Peritoneal Membrane: AlloMEM™ | Experimental | Biological: AlloMEM™For use as a homologous tissue where native peritoneum is absent or traumatized. By decreasing adhesions and providing a peritoneal remodeling capacity, both the time needed for ileostomy closure and the risk of enterotomy or seromyotomy would be reduced. The combination could lead to decreased complication rates and therefore decreased morbidity for the surgical patients requiring an ileostomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Between 18 - 85 years old at the time of ileostomy formation
- Scheduled to undergo planned diverting loop ileostomy
Key exclusion criteria (3 listed)
- Patients undergoing emergency surgery
- Patients with abdominal or pelvic abscess present at time of initial surgery
- Patients with a history of pulmonary embolism or deep vein thrombosis (DVT) within 1 year of surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlloMEM™Also: Human Peritoneal MembraneTo investigate whether the use of HPM in a temporary loop ileostomy is beneficial to patients. | Biological | Human Peritoneal Membrane: AlloMEM™ |
Primary outcome
If there is a decrease on adhesion formation of AlloMEM™ used in formation of a temporary loop ileostomy.
Time frame: Average 1 hour during formation of ileostomy
Change in adhesion formation will be analyzed via the primary outcome of ileostomy mobilization time during ileostomy closure and the secondary outcome of an adhesion grading scale.
1 secondary outcome
Decrease in operative time and a promotion of peritoneal remodeling
Time frame: During 3 month ileostomy closure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Background: PubMed 19628227Jin J, Voskerician G, Hunter SA, McGee MF, Cavazzola LT, Schomisch S, Harth K, Rosen MJ. Human peritoneal membrane controls adhesion formation and host tissue response following intra-abdominal placement in a porcine model. J Surg Res. 2009 Oct;156(2):297-304. doi: 10.1016/j.jss.2009.04.010. Epub 2009 May 13.
- Derived from this study: PubMed 23670746Keller DS, Champagne BJ, Stein SL, Ermlich BO, Delaney CP. Pilot study evaluating the efficacy of AlloMEM for prevention of intraperitoneal adhesions and peritoneal regeneration after loop ileostomy. Surg Endosc. 2013 Oct;27(10):3891-6. doi: 10.1007/s00464-013-3004-6. Epub 2013 May 14.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Conor P. Delaney, MD, PhD principal investigator
University Hospitals Cleveland Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AlloMEM™ in people with Colon Cancer and Rectal Cancer, run by University Hospitals Cleveland Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
If there is a decrease on adhesion formation of AlloMEM™ used in formation of a temporary loop ileostomy. (time frame: Average 1 hour during formation of ileostomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01113736, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022.